A5078412985- Ethics in Clinical Research
- Data Quality and Management
- Electronic Health Records Systems
- Health and Medical Studies
- Medical and Health Sciences Research
- Biomedical Ethics and Regulation
- Scientific Computing and Data Management
- Digitalization, Law, and Regulation
- Palliative Care and End-of-Life Issues
- Patient-Provider Communication in Healthcare
- Clinical practice guidelines implementation
- Privacy-Preserving Technologies in Data
- Patient Dignity and Privacy
- Data Analysis with R
- Healthcare Decision-Making and Restraints
- Mental Health and Psychiatry
- Injury Epidemiology and Prevention
- Data-Driven Disease Surveillance
- Bioinformatics and Genomic Networks
- Healthcare cost, quality, practices
- Wound Healing and Treatments
- Statistical Methods and Bayesian Inference
- Nutritional Studies and Diet
- Biomedical Text Mining and Ontologies
- Ethics and Legal Issues in Pediatric Healthcare
Universitätsmedizin Greifswald
2015-2024
Universität Greifswald
2023
Institute for Community Health
2015
COVID-19 has challenged the healthcare systems worldwide. To quickly identify successful diagnostic and therapeutic approaches large data sharing are inevitable. Though organizational clinical abundant, many of them available only in isolated silos largely inaccessible to external researchers. overcome tackle this challenge university medicine network (comprising all 36 German hospitals) been founded April 2020 coordinate action plans, strategies collaborative research activities. 13...
Cohort studies and registries rely on massive amounts of personal medical data. Therefore, data protection information security as well ethical aspects gain in importance need to be considered early possible during the establishment a study. Resulting legal obligations require precise implementation appropriate technical organisational measures for Trusted Third Party.This paper defines organises consistent workflow-management realize Party. In particular, it focusses Party Dispatcher...
Summary Introduction: In the context of an increasing number multi-centric studies providing data from different sites and sources necessity for central management (CDM) becomes undeniable. This is exacerbated by a multiplicity featured types, formats interfaces. relation to methodological medical research definition needs be broadened beyond simple storage archiving data. Objectives: paper highlights typical requirements CDM cohort registries illustrates how orientation can provided...
Abstract Background The aim of the German Medical Informatics Initiative is to establish a national infrastructure for integrating and sharing health data. To this, Data Integration Centers are set up at university medical centers, which address data harmonization, information security protection. capture patient consent, common informed consent template has been developed. It consists different modules addressing permissions using biosamples. On technical level, digital representation from...
The use of medical data for research purposes requires an informed consent the patient that is compliant with EU General Data Protection Regulation. In context multi-centre initiatives and a multitude clinical epidemiological studies scalable automatable measures digital management are required. Modular form, structure, contents render patient's reusable varying project settings in order to effectively manage minimise organisational technical efforts. Within DFG-funded "MAGIC" (Grant Number...
The Federal Ministry of Education and Research Germany (BMBF) funds a network university medicines (NUM) to support COVID-19 pandemic research at national level. "COVID-19 Data Exchange Platform" (CODEX) as part NUM establishes harmonised infrastructure that supports use datasets. broad consent (BC) the Medical Informatics Initiative (MII) is agreed by all German federal states forms legal base for data processing. All 34 participating hospitals (NUM sites) work upon infrastructural well...
Abstract Background Defining and protecting participants’ rights is the aim of several ethical codices legal regulations. According to these regulations, Informed Consent (IC) an inevitable element research with human subjects. In era “big data medicine”, aspects IC become even more relevant since becomes complex rendering compliance regulations increasingly difficult. Methods Based on literature practical experiences gathered by Institute for Community Medicine (ICM), University Greifswald,...
Epidemiological studies are based on a considerable amount of personal, medical and socio-economic data. To answer research questions with reliable results, epidemiological projects face the challenge providing high quality Consequently, gathered data has to be reviewed continuously during collection period.This article describes development mosaicQA-library for non-statistical experts consisting set reusable R functions provide support basic assurance wide range application scenarios in...
In most research projects budget, staff and IT infrastructures are limiting resources. Especially for small-scale registries cohort studies professional support commercial electronic data capture systems too expensive. Consequently, these use simple local approaches (e.g. Excel) instead of a central management including web-based proper databases. This leads to manual processes merge, analyze and, if possible, pseudonymize different study sites. To multi-site capture, storage analyses in...
Abstract Background The consent management is an essential component for supporting the implementation of consents and withdrawals thus, realisation patient’s rights. In MIRACUM, one four consortia Medical Informatics Initiative (MII), ten university hospitals intend to integrate generic Informed Consent Service® (gICS) in their Data Integration Center (DIC). To provide a tool that supports local workflows MIRACUM sites, gICS should be improved. Methods We used three standardised...
Abstract Background The identity management is a central component in medical research. Patients are recruited from various sites, which requires an error tolerant record linkage method, to ensure that patients registered only once. In large research projects or institutions, the has deal with several thousands millions of patients. environments numbers register process could lead high runtimes caused by linkage. Central Biomaterial Bank Charité (ZeBanC) searched for solution, can handle...
Abstract Introduction The informed consent is the legal basis for research with human subjects. Therefore, form (CF) as legally binding document must be valid, that is, completely filled-in stating person's decision clearly and signed by respective person. However, especially paper-based CFs might have quality issues transformation into machine-readable information could add to low quality. This paper evaluates arising of using example Baltic Fracture Competence Centre (BFCC) fracture...
Availability and accessibility are important preconditions for using real-world patient data across organizations. To facilitate enable the analysis of collected at a large number independent healthcare providers, syntactic- semantic uniformity need to be achieved verified. With this paper, we present transfer process implemented Data Sharing Framework ensure only valid pseudonymized is transferred central research repository feedback on success or failure provided. Our implementation used...
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In German and international research networks different approaches concerning patient consent are applied. So far it is time-consuming to find out what extent data from these can be used for a specific project. To make the contents of consents queryable, we aimed permission-based approach (Opt-In) that map both permission withdrawal as well queryable beyond project boundaries.
Introduction: Medical research studies which involve electronic data capture of sensitive about human subjects need to manage medical and identifying participant in a secure manner. To protect the identity subjects, an independent trusted third party should be responsible for pseudonymization management data. Methods: We have developed web-based integrated solution that combines REDCap as system with software tools University Medicine Greifswald, provides study personnel single user...
Abstract The EyeMatics project, embedded as a clinical use case in Germany’s Medical Informatics Initiative, is large digital health initiative ophthalmology. objective to improve the understanding of treatment effects intravitreal injections, most frequent procedure treat eye diseases. To achieve this, valuable patient data will be meaningfully integrated and visualized from different IT systems hospital sites. emphasizes governance framework that actively involves representatives, strictly...
Enrolling in a clinical trial or study requires informed consent. Furthermore, it is crucial to ensure proper consent when storing samples biobanks for future research, as these may be used studies beyond their initial purpose. For pediatric studies, must obtained from both the child and legal guardians, requiring recording of multiple consents at once. Electronic has become more popular recently due its ability prevent errors simplify documentation consents. However, integrating capture...
Pseudonymization is an important aspect of projects dealing with sensitive patient data. Most build their own specialized, hard-coded, solutions. However, these overlap in many aspects functionality. As any re-implementation binds resources, we would like to propose a solution that facilitates and encourages the reuse existing components. We analyzed already-established data protection concepts gain insight into common features ways which components were linked together. found could...
Abstract BackgroundThe Federal Ministry of Research and Education funded the Network University Medicine for establishing an infrastructure pandemic research. This includes development a COVID-19 Data Exchange Platform (CODEX) that provides standardised harmonised data sets Nearly all university hospitals in Germany are part project transmit medical from local integration centres to CODEX platform. The on person has been collected at several sites is be made available platform merged form....
The TMF (Technology, Methods, and Infrastructure for Networked Medical Research) Data Protection Guide (TMF-DP) makes path-breaking recommendations on the subject of data protection in research projects. It includes comprehensive requirements applications such as patient lists, pseudonymization services, consent management services. Nevertheless, it lacks a structured, categorized list simplified application projects systematic evaluation. 3LGM2IHE ("Three-layer Graphbased meta model -...
ObjectiveIn numerous German and international research networks projects that collect personal health data, different approaches to how a participant consent looks like exist. In Germany, data usage for medical is thus far consented in the Opt-In system. order make contents of consents queryable, we have searched purely permission-based approach, which can map both permission withdrawal as well them queryable without overlaps.MethodsQuery solutions from two were compared such way overlapping...